Led by George D. Dangas, MD, PhD, FACC, the trial evaluated the superiority of bivalirudin as an alternative to heparin in procedural anticoagulation in 802 TAVR patients. The primary endpoints included major bleeding within 48 hours or before hospital discharge, and 30-day net adverse clinical events.

The study showed that bivalirudin was not superior to heparin, as neither the rates of major bleeding (6.9 vs. 9.0 percent, respectively) nor the rates of 30-day net adverse clinical events (14.4 vs. 16.1 percent, respectively) were significantly lowered. However, bivalirudin proved noninferior to heparin, indicating that bivalirudin may be an alternative anticoagulant for TAVR patients unable to take heparin.

“Bivalirudin appears to be a reasonable alternative to [heparin] for TAVR,” states Sunil V. Rao, MD, FACC, in an accompanying editorial comment. “However, the cost difference between the two agents begs the question of when bivalirudin should be considered.”

Rao adds that “there is no question that until further data are available, [heparin] is the preferred agent for TAVR.”